Insulin Degludec and Glargine U100 for Management of Hospitalized and Discharged Patients With Type 2 Diabetes

Emory University

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes

Treatments: Drug: Glargine; Drug: Degludec; Drug: Aspart

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03336528

IRB00087816

Details and patient eligibility

About

The purpose of this study is to find out if treatment with degludec insulin when compared to glargine U100 insulin will result in similar blood sugar control in patients with diabetes who are admitted to the hospital and then transition to home after discharge from the hospital.

Full description

Degludec is a new generation basal insulin analog with a longer duration of action compared to insulin glargine. Several outpatient trials have reported that treatment with degludec results in comparable improvement in HbA1c levels and in lower rates of hypoglycemia compared to glargine U100 insulin. However, no previous studies have compared the safety and efficacy of the long-acting basal insulin degludec in the inpatient management of patients with diabetes. It is expected that a large number of patients with diabetes will be started on or transitioned to this new insulin formulation so acquiring knowledge on the safety and efficacy of degludec insulin is of great clinical interest. Accordingly, the proposed study will provide novel and clinically useful information on the efficacy (assessed as blood glucose control) and safety (assessed as hypoglycemia) of degludec in the inpatient setting and after hospital discharge in general medicine and surgery patients with Type 2 Diabetes (T2D).

Participants will be randomized to receive either a basal bolus with degludec or glargine U100 once daily during hospitalization. All participants will receive aspart insulin before meals. Participants with poorly controlled diabetes during the inpatient portion of the study will be invited to participate in the outpatient portion of the study. Participants in the outpatient portion of the study will be discharged on their preadmission oral antidiabetic medications plus degludec or glargine once daily, based on the study medication they were randomized to take during the inpatient portion of the study.

Enrollment: 180 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Males or females > 18 years of age who are admitted to a general medicine or surgical service
2. A known history of T2D treated either with diet alone, oral monotherapy, any combination of oral antidiabetic agents, short-acting glucagon-like peptide-1 receptor agonists (GLP-1 RA) or insulin therapy except for degludec and glargine U300
3. Subjects with diet alone and HbA1c>7.0%
4. Medical and surgical patients expected to be admitted length of stay (LOS) longer than 2 days
5. Subjects must have a randomization BG > 140 mg and < 400 mg/dL without laboratory evidence of diabetic ketoacidosis (bicarbonate < 18 milliequivalent (mEq)/L, potential of hydrogen (pH) < 7.30, or positive serum or urinary ketones)
6. Signed, informed consent and HIPAA documentation prior to any study procedures

Exclusion criteria

1. Subjects with increased BG concentration, but without a known history of diabetes (stress hyperglycemia)
2. Subjects treated with diet alone (no antidiabetic agents) and admission HbA1c <7%
3. Admission or pre-randomization BG≥400 mg/dL
4. Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria
5. Patients treated with degludec or glargine U300, or with long-acting weekly GLP-1 RA (weekly exenatide, dulaglutide or albiglutide)
6. Patients with acute critical or surgical illness admitted to the ICU except for observation (<24 hours and did not require vasopressors and/or mechanical ventilation)
7. Patients with history of clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), ongoing corticosteroid therapy (equal to a prednisone dose ≥5 mg/day), or impaired renal function (eGFR< 30 ml/min), or congestive heart failure (NYHA- IV)
8. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
9. Female subjects who are pregnant or breast feeding at time of enrollment into the study
10. Known or suspected allergy to trial medication(s), excipients, or related products
11. Previous participation in this trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

180 participants in 2 patient groups

Degludec inpatient

Experimental group

Description:

Study participants treated with insulin prior to admission will receive 80% or 100% of the total daily dose (TDD) given as a basal bolus regimen with degludec once daily plus rapid-acting aspart insulin before meals.

Treatment:

Drug: Aspart

Drug: Degludec

Glargine U100 inpatient

Active Comparator group

Description:

Study participants treated with insulin prior to admission will receive 80% or 100% of the total daily dose (TDD) given as basal bolus regimen with glargine once daily plus rapid-acting aspart insulin before meals.

Treatment:

Drug: Aspart

Drug: Glargine